Analytical Method Development and Validation of Vortioxetine Hydrobromide by RP HPLC on Bulk and Tablet Dosage Form

Purpose A simple, rapid, highly sensitive, selective, specific, robust RP HPLC method has been developed and validated for the estimation of Vortioxetine HBr in bulk and Tablet Dosage form. Methods The Chromatographic separation was obtained using a mobile phase ACN Methanol Water 40 50 10V V on column Cosmosil C18 250mm x 4.6ID, Particle size 5 micron at 30 with UV detection 370 nm at flow rate 0.8 ml min. The linearity was found to be 10 50µg ml. The retention time was found to be 4.498 min. Results The method was validated according to ICH. The correlation coefficient r2 of HPLC method was found to be 0.9991. The LOD and LOQ were found to be 0.23927µg ml and 0.72507 µg ml respectively. The intra day and inter day precision and accuracy values for method were found to be = 2 RSD. Conclusion The Proposed RP HPLC method has been successfully applied to the commercial tablets without any interference of excipients. The method can be used for the routine analysis in industry for Vortioxetine HBr in bulk and tablet dosage forms. Avinash Gajanan Tapkire | Rishikesh S. Bachhav "Analytical Method Development and Validation of Vortioxetine Hydrobromide by RP-HPLC on Bulk and Tablet Dosage Form" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-2 , February 2022, URL: https://www.ijtsrd.com/papers/ijtsrd49368.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/49368/analytical-method-development-and-validation-of-vortioxetine-hydrobromide-by-rphplc-on-bulk-and-tablet-dosage-form/avinash-gajanan-tapkire